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Articles Tagged withAmerican Medical Systems (AMS)

AMS-Endo announces Vaginal Mesh lawsuit final settlement, as reported by Bloomberg News. Endo Pharmaceuticals, the owner of American Medical System (AMS) agreed to another $775 million to settle vaginal mesh injury lawsuits.

AMS-Endo Announces Vaginal Mesh Lawsuit final settlement. AMS-Endo Vaginal mesh and bladder sling for repair of pelvic organ prolapse and urinary incontinence may lead to pain, further surgery, recurrence of symptoms and erosion of the devices through soft tissue.

Endo has paid more than $2.6 billion to settle “virtually all known” vaginal injury claims.

Encouraging news for some women who have been injured by the transvaginal mesh debacle. Endo International Plc, the owner of AMS, has agreed to settle its product liability transvaginal mesh lawsuits that allege its line of vaginal-mesh implants caused personal injury by eroding through the vagina in some women and left them in pain and exposed to serious infections.

According to Endo, they settled “substantially all” the remaining U.S. lawsuits against its American Medical Systems Holdings unit over the Perigee, Apogee and Elevate mesh implants. Endo announced that the company was adding $400 million to its $1.2 billion liability reserve for the devices. These vaginal mesh devices were designed to support pelvic muscles and treat incontinence.

The deal settles more than 10,000 lawsuits. Endo agreed earlier this year to pay about $830 million to settle an additional 20,000 suits over the implants. That settlement was announced after the U.S. Food and Drug Administration said vaginal-mesh inserts should be subject to stricter safety requirements because they are high-risk devices.

Endo Health Solutions Inc., said it will pay about $830 million to settle most transvaginal lawsuits. Thousands of injured women allege that its vaginal-mesh implants eroded, left them incontinent and made sex painful.

https://www.youtube.com/watch?v=0Xvv9cd07G8&feature=player_detailpage

Endo’s American Medical Systems Inc. unit reported that it’s settling about 20,000 law suit product liability injury claims over the medical devices, which include the Perigee, Apogee and Elevate implants. Endo, a medical device company based in Ireland, is still exposed to at least 5,000 injury claims against AMS, including some that have been consolidated for pretrial proceedings in West Virginia.

The Ethicon Gynecare pelvic mesh and bladder sling products have been under fire for causing severe and debilitating injuries when the mesh erodes through the vagina, causing serious infections and the need for revision surgeries.

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

As a Texas Vaginal Mesh attorney, and Dallas medical doctor, we are reporting this important potential transvaginal mesh settlement breakthrough. According to sources, C.R. Bard Inc., and other makers of vaginal-mesh implants, are in advanced talks to settle thousands of vaginal mesh product liability lawsuits.

Transvaginal mesh injury lawsuits are consolidated and coordinated in 6 individual multidistrict litigations (MDLs) established in the federal court system. These injury claims against vaginal mesh manufacturers have now become the largest pending litigation in the U.S.

30,000 Active Mesh Lawsuits and Climbing

There are more than 30,000 complaints filed in U.S. District Courts over injuries with transvaginal mesh and bladder sling products. These medical devices have been used for treatment of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

According to reports, C.R. Bard Inc., has agreed to settle a one of its Avaulta vaginal-mesh implant lawsuits, which allegedly caused severe urinary problems. This case was set for trial this month in New Jersey.

Bard agreed to pay an undisclosed sum to resolve Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems. Virgil’s case had been set for a Sept. 23 trial in state court in Atlantic City.

According to the filings, the 56-year-old woman said she needed three surgeries to address urinary problems created by the insert.

Recently, Bard settled the second federal Avaulta bellwether trial over its alleged defective transvaginal mesh devices. The settlement was announced by U.S. District Judge Goodwin, who is supervising the transvaginal mesh product liability lawsuits in Charleston, W.Va.

As previously noted, in the first Bard Avaulta bellwether trial, the jury awarded $2 million to a woman who claimed that Bard failed to warn of defects in its product that caused her mesh side effects. The settlement ended the second trial, brought by a North Carolina woman, Wanda Queen. A third bellwether case goes to trial on October 8 and a fourth on November 4.

Last week, a federal jury in West Virginia awarded $2 million in damages in a Bard Avaulta vaginal mesh defective product liability claim. The verdict included punitive damages to punish CR Bard Inc., the manufacturer for selling a defective product that has been linked to severe internal injuries.

This is the first federal Vaginal Mesh verdict, in more than 25,000 vaginal mesh lawsuits pending in the federal court system.

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